OTIVIDEX™

OTIVIDEX is a sustained-exposure formulation of the steroid dexamethasone. Otonomy has suspended all development activities for OTIVIDEX following the failure of AVERTS-1, the U.S. Phase 3 trial of OTIVIDEX in patients with Ménière’s disease. The clinical trial missed its primary endpoint which was the count of definitive vertigo days by Poisson Regression analysis (p=0.62). Patients in both the OTIVIDEX and placebo groups showed similar reductions in the number and severity of vertigo episodes during the three month observation period. OTIVIDEX patients reported a 58% reduction from baseline in vertigo frequency in Month 3 vs. 55% for placebo patients. The trial also failed to achieve statistical significance (p < 0.05) for any of the key secondary vertigo endpoints at Month 3.